10-Q: Quarterly report pursuant to Section 13 or 15(d)
Published on November 14, 2018
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2018
OR
☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ________ to ________
Commission File Number: 001-38662
SUTRO BIOPHARMA, INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware |
47-0926186 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer |
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310 Utah Avenue, Suite 150 South San Francisco, California |
94080 |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (650) 392-8412
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☐ No ☒
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Accelerated filer |
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☐ |
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Non-accelerated filer |
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☒ |
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Smaller reporting company |
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☐ |
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Emerging growth company |
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☒ |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of November 9, 2018, the registrant had 22,848,184 shares of common stock, $0.001 par value per share, outstanding.
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Page |
PART I. |
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Item 1. |
1 |
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1 |
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2 |
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3 |
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4 |
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5 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
28 |
Item 3. |
39 |
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Item 4. |
39 |
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PART II. |
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Item 1. |
40 |
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Item 1A. |
40 |
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Item 2. |
81 |
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Item 3. |
82 |
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Item 4. |
82 |
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Item 5. |
82 |
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Item 6. |
83 |
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84 |
i
Sutro Biopharma, Inc.
(In thousands, except share and per share amounts)
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September 30, |
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December 31, |
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2018 |
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2017 |
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(Unaudited) |
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(See Note 2) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
41,353 |
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$ |
22,020 |
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Marketable securities |
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81,597 |
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– |
|
Accounts receivable, net (including amounts from related parties of $1,695 and $784 as of September 30, 2018 and December 31, 2017, respectively) |
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2,443 |
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|
1,624 |
|
Prepaid expenses and other current assets |
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1,979 |
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1,985 |
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Total current assets |
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127,372 |
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25,629 |
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Property and equipment, net |
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11,673 |
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13,997 |
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Other long-term assets |
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5,966 |
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1,128 |
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Restricted cash |
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15 |
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15 |
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Total assets |
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$ |
145,026 |
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$ |
40,769 |
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Liabilities, Redeemable Convertible Preferred Stock, and Stockholders’ Deficit |
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Current liabilities: |
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Accounts payable |
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$ |
4,594 |
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$ |
2,902 |
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Accrued compensation |
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4,085 |
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3,639 |
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Deferred revenue—current |
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24,229 |
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10,709 |
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Debt—current |
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3,182 |
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14,634 |
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Other current liabilities |
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815 |
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72 |
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Total current liabilities |
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36,905 |
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31,956 |
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Deferred revenue, non-current |
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48,805 |
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13,159 |
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Deferred rent |
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473 |
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428 |
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Redeemable convertible preferred stock warrant liability |
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|
867 |
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1,708 |
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Debt—non-current |
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11,500 |
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– |
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Other noncurrent liabilities |
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664 |
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14 |
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Total liabilities |
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99,214 |
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47,265 |
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Commitments and Contingencies |
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Redeemable convertible preferred stock, $0.001 par value — 498,070,991 and 177,082,393 shares authorized as of September 30, 2018 and December 31, 2017, respectively; 493,615,703 and 173,750,421 shares issued and outstanding as of September 30, 2018 and December 31, 2017, respectively; aggregate liquidation preference of $188,639 as of September 30, 2018 |
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187,246 |
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102,505 |
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Stockholders’ deficit: |
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Common stock, $0.001 par value — 818,000,000 and 271,000,000 shares authorized as of September 30, 2018 and December 31, 2017, respectively; 485,097 and 465,330 shares issued and outstanding as of September 30, 2018 and December 31, 2017, respectively |
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– |
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– |
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Note receivable from stockholder |
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– |
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(208 |
) |
Additional paid-in-capital |
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7,428 |
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6,218 |
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Accumulated other comprehensive loss |
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(27 |
) |
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– |
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Accumulated deficit |
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(148,835 |
) |
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(115,011 |
) |
Total stockholders’ deficit |
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(141,434 |
) |
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(109,001 |
) |
Total liabilities, redeemable convertible preferred stock, and stockholders’ deficit |
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$ |
145,026 |
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$ |
40,769 |
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See accompanying notes to unaudited interim condensed financial statements.
1
Condensed Statements of Operations
(Unaudited)
(In thousands, except share and per share amounts)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2018 |
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2017 |
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2018 |
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2017 |
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Revenue: |
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Collaboration revenue (including amounts from related parties of $5,174 and $8,529 during the three and nine months ended September 30, 2018, and $15,754 and $42,292 during the three and nine months ended September 30, 2017) |
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$ |
6,924 |
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$ |
17,499 |
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$ |
13,955 |
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$ |
47,701 |
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Other revenue—related parties |
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912 |
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– |
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5,378 |
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– |
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Total revenue |
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7,836 |
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17,499 |
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19,333 |
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47,701 |
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Operating expenses |
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Research and development |
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12,642 |
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13,669 |
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39,475 |
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39,499 |
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General and administrative |
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5,351 |
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4,895 |
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13,806 |
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12,306 |
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Total operating expenses |
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17,993 |
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18,564 |
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53,281 |
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51,805 |
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Loss from operations |
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(10,157 |
) |
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(1,065 |
) |
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(33,948 |
) |
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(4,104 |
) |
Interest income |
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403 |
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62 |
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483 |
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192 |
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Interest expense |
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(415 |
) |
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(235 |
) |
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(1,199 |
) |
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(235 |
) |
Other income (expense), net |
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(68 |
) |
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(180 |
) |
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|
840 |
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(197 |
) |
Net loss |
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$ |
(10,237 |
) |
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$ |
(1,418 |
) |
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$ |
(33,824 |
) |
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$ |
(4,344 |
) |
Net loss per share, basic and diluted |
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$ |
(21.26 |
) |
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$ |
(3.14 |
) |
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$ |
(71.06 |
) |
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$ |
(9.77 |
) |
Weighted-average shares used in computing net loss per share |
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481,613 |
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451,550 |
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476,023 |
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444,594 |
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See accompanying notes to unaudited interim condensed financial statements.
2
Condensed Statements of Comprehensive Loss
(Unaudited)
(In thousands)
|
Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2018 |
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2017 |
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2018 |
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2017 |
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Net loss |
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$ |
(10,237 |
) |
|
$ |
(1,418 |
) |
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$ |
(33,824 |
) |
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$ |
(4,344 |
) |
Other comprehensive income: |
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Unrealized gain (loss) on available-for-sale securities |
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(27 |
) |
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5 |
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(27 |
) |
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16 |
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Comprehensive loss |
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$ |
(10,264 |
) |
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$ |
(1,413 |
) |
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$ |
(33,851 |
) |
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$ |
(4,328 |
) |
See accompanying notes to unaudited interim condensed financial statements.
3
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(In thousands)
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Nine Months Ended |
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September 30, |
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2018 |
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2017 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(33,824 |
) |
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$ |
(4,344 |
) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: |
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Depreciation and amortization |
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3,404 |
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3,796 |
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Amortization of premium (accretion of discount) on marketable securities |
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(166 |
) |
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116 |
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Stock-based compensation |
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|
802 |
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1,126 |
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Revaluation of SutroVax option liability |
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48 |
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|
75 |
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Revaluation of redeemable convertible preferred stock warrant liability |
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(839 |
) |
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|
186 |
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Accretion of debt discount |
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119 |
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24 |
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Loss on disposal of property and equipment |
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35 |
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|
87 |
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Other revenue |
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|
140 |
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|
– |
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Changes in operating assets and liabilities: |
|
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|
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|
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Accounts receivable |
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(819 |
) |
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(10,279 |
) |
Prepaid expenses and other current assets |
|
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(901 |
) |
|
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(302 |
) |
Accounts payable |
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(135 |
) |
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|
178 |
|
Accrued compensation |
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|
446 |
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|
|
(178 |
) |
Other liabilities |
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|
1,097 |
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|
|
106 |
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Deferred rent |
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|
45 |
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|
56 |
|
Deferred revenue |
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49,166 |
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|
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(22,881 |
) |
Net cash provided by (used in) operating activities |
|
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18,618 |
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(32,234 |
) |
Cash flows from investing activities: |
|
|
|
|
|
|
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Purchases of marketable securities |
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|
(81,456 |
) |
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|
(5,019 |
) |
Maturities of marketable securities |
|
|
– |
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|
32,650 |
|
Sales of marketable securities |
|
|
– |
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|
|
6,000 |
|
Purchases of property and equipment |
|
|
(759 |
) |
|
|
(2,659 |
) |
Net cash provided by (used in) investing activities |
|
|
(82,215 |
) |
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|
30,972 |
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Cash flows from financing activities: |
|
|
|
|
|
|
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|
Proceeds from issuance of debt |
|
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– |
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|
15,000 |
|
Payments of debt issuance fees |
|
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– |
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|
|
(171 |
) |
Payments of deferred offering costs |
|
|
(2,413 |
) |
|
|
(74 |
) |
Proceeds from payment of note receivable by stockholder |
|
|
208 |
|
|
|
– |
|
Proceeds from issuances of common stock upon exercise of warrants |
|
|
2 |
|
|
|
– |
|
Proceeds from issuances of common stock upon exercise of stock options |
|
|
394 |
|
|
|
61 |
|
Proceeds from issuance of redeemable convertible preferred stock, net of issuance costs |
|
|
84,739 |
|
|
|
– |
|
Net cash provided by financing activities |
|
|
82,930 |
|
|
|
14,816 |
|
Net increase in cash and cash equivalents |
|
|
19,333 |
|
|
|
13,554 |
|
Cash, cash equivalents, and restricted cash—beginning of period |
|
|
22,035 |
|
|
|
11,868 |
|
Cash, cash equivalents, and restricted cash—end of period |
|
$ |
41,368 |
|
|
$ |
25,422 |
|
Supplemental disclosure of cash flow information: |
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|
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Cash paid for interest |
|
$ |
942 |
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|
$ |
184 |
|
Supplemental disclosure of non-cash investing and financing information: |
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Vesting of early exercised shares |
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$ |
14 |
|
|
$ |
65 |
|
Purchase of property and equipment included in accounts payable |
|
$ |
610 |
|
|
$ |
229 |
|
Deferred initial public offering costs included in accounts payable |
|
$ |
1,659 |
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|
$ |
85 |
|
See accompanying notes to unaudited interim condensed financial statements.
4
Notes to Unaudited Interim Condensed Financial Statements
1. Organization and Principal Activities
Description of Business
Sutro Biopharma, Inc. (the “Company”) is a clinical stage drug discovery, development and manufacturing company focused on leveraging its integrated cell-free protein synthesis and site-specific conjugation platform, XpressCF+™, to create a broad variety of optimally designed, next-generation protein therapeutics for cancer and autoimmune disorders. The Company was incorporated on April 21, 2003, and was formerly known as Fundamental Applied Biology, Inc. The Company is headquartered in South San Francisco, California.
The Company operates in one business segment, the development of biopharmaceutical products.
Initial Public Offering
On September 26, 2018, the Company’s registration statements on Form S-1 (File No. 333-227103 and 333-227548) relating to its initial public offering (“IPO”) of its common stock was declared effective by the Securities and Exchange Commission (“SEC”) and the shares of its common stock began trading on the Nasdaq Global Market on September 27, 2018. The public offering price of the shares sold in the IPO was $15.00 per share. The IPO closed on October 1, 2018, pursuant to which the Company sold 5,667,000 shares of common stock, for gross proceeds of approximately $85.0 million. The Company received net proceeds from the IPO of approximately $74.4 million, after underwriting discounts, commissions and estimated offering expenses. In addition to the shares of common stock sold in the IPO, the Company concurrently sold in a private placement to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (“Merck”), 666,666 shares of common stock at the IPO offering price of $15.00 per share, for proceeds of approximately $10.0 million. Immediately prior to the completion of the IPO, all outstanding shares of redeemable convertible preferred stock converted into common stock.
Immediately prior to the completion of the IPO on October 1, 2018, all outstanding shares of redeemable convertible preferred stock were converted into 16,028,462 shares of common stock. Subsequent to the closing of the IPO, there were no shares of redeemable convertible preferred stock outstanding. The condensed financial statements as of September 30, 2018, including share and per share amounts, do not give effect to the IPO, or the conversion of the redeemable convertible preferred stock, as the IPO and such conversions were completed subsequent to September 30, 2018.
Reverse Stock Split
On September 14, 2018, the Company effected a reverse split of all shares of its common stock at a ratio of 36.3-for-1. Upon the effectiveness of the reverse stock split, (i) all shares of outstanding common stock were adjusted; (ii) the number of shares of common stock for which each outstanding option to purchase common stock is exercisable were adjusted; (iii) the exercise price of each outstanding option to purchase common stock were adjusted; (iv) the conversion ratio for each share of outstanding redeemable convertible preferred stock which is convertible into the Company’s common stock was proportionately reduced; (v) the number of shares of common stock for which each outstanding warrant to purchase common stock is exercisable was proportionally decreased; (vi) the conversion ratio for each outstanding warrant to purchase redeemable convertible preferred stock which is convertible into warrants to purchase the Company’s common stock after the offering was proportionally decreased; and (vii) the exercise price of each outstanding warrant was proportionally increased. All of the outstanding common stock share numbers (including shares of common stock subject to the Company’s options, as converted for the outstanding redeemable convertible preferred stock shares and warrants), share prices, exercise prices and per share amounts contained in the financial statements have been retroactively adjusted in the financial statements to reflect this reverse stock split for all periods presented. The par value per share and the authorized number of shares of common stock and redeemable convertible preferred stock were not adjusted as a result of the reverse stock split.
Series E Redeemable Convertible Preferred Stock Split
In July 2018, the Company’s board of directors approved an amendment to the Company’s amended and restated certificate of incorporation to effect a 1-for-1.1940912491 split (“Split”) of shares of the Company’s Series E redeemable convertible preferred stock, which was effected on July 26, 2018. The par value and authorized shares of redeemable convertible preferred stock and the other outstanding shares of redeemable convertible preferred stock were not adjusted as a result of the Split. All of the outstanding Series E redeemable convertible preferred shares and per share information included in the accompanying financial statements have been adjusted to reflect the Split.
5
The Company has incurred significant losses and has negative cash flows from operations. As of September 30, 2018, there was an accumulated deficit of $148.8 million. Management expects to continue to incur additional substantial losses in the foreseeable future as a result of the Company’s research and development activities.
As of September 30, 2018, the Company had unrestricted cash, cash equivalents and marketable securities of $123.0 million, which is available to fund future operations. The Company will need to raise additional capital to support the completion of its research and development activities. The Company’s activities are subject to significant risks and uncertainties, including failing to secure additional funding to continue to operationalize the Company’s current technology and to advance the development of its product candidates.
The Company believes that its unrestricted cash, cash equivalents and marketable securities as of September 30, 2018 will be sufficient for the Company to continue as a going concern for at least one year from the issuance date of its unaudited interim condensed financial statements.
In August 2017, the Company entered into a loan and security agreement with Oxford Finance LLC (“Oxford”) and Silicon Valley Bank (“SVB”) under which it borrowed $15.0 million (the “August 2017 Loan”) (see Note 6). The August 2017 Loan provides that an event of default will occur if, among other triggers, there occurs any circumstances that could reasonably be expected to result in a material adverse effect on the Company’s business, operations or condition, or on its ability to perform its obligations under the loan. The Company disclosed in its audited financial statements as of December 31, 2017 that the Company believed that there was substantial doubt about its ability to continue as a going concern given its continuing operating losses and its then current available capital resources, which could be deemed to be an event of default if such condition was considered to have a material adverse effect on the Company’s business, operations or condition. As a result, the Company classified the entire debt balance as a current liability as of December 31, 2017 given that a determination of such an event of default was outside of the Company’s control. Based on the available financial resources described above, as of September 30, 2018, the Company has classified $3.2 million of the outstanding debt balance as current and the remainder as non-current, which reflects the scheduled repayments under the August 2017 Loan.
2. Summary of Significant Accounting Policies
Basis of Presentation and Use of Estimates
The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates on historical experience and market-specific or other relevant assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s balance sheets and the amount of expenses and income reported for each of the periods presented are affected by estimates and assumptions, which are used for, but are not limited to, determining research and development periods under multiple element arrangements, stock-based compensation expense, fair value of redeemable convertible preferred stock and warrant liabilities, fair value of common stock, income taxes and certain accrued liabilities. Actual results could differ from such estimates or assumptions.
Unaudited Interim Condensed Financial Statements
The interim condensed balance sheet as of September 30, 2018, the condensed statements of operations and comprehensive loss for the three and nine months ended September 30, 2018 and 2017, and the condensed statements of cash flows for the nine months ended September 30, 2018 and 2017 are unaudited. The unaudited interim condensed financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s financial position as of September 30, 2018, its results of operations and comprehensive loss for the three and nine months ended September 30, 2018 and 2017, and cash flows for the nine months ended September 30, 2018 and 2017. The financial data and the other financial information contained in these notes to the condensed financial statements related to the three-month and nine-month periods are also unaudited. The results of operations for the three and nine months ended September 30, 2018 are not necessarily indicative of the results to be expected for the year ending December 31, 2018 or for any other future annual or interim period. The condensed balance sheet as of December 31, 2017 included herein was derived from the audited financial statements as of that date. These condensed financial statements should be read in conjunction with the Company's audited financial statements included in the prospectus dated September 26, 2018 that forms a part of the Company's registration statements on Form S-1 (File Nos 333-227103 and 333-227548), as filed with the SEC pursuant to Rule 424(b)(4) promulgated under the Securities Act of 1933, as amended.
6
Cash, Cash Equivalents, and Restricted Cash
The Company considers all highly liquid investments with original maturities of 90 days or less from the date of purchase to be cash equivalents.
Under certain lease and credit agreements, the Company has pledged cash and cash equivalents as collateral. Restricted cash related to such agreements was $15,000 as of both September 30, 2018 and December 31, 2017.
The following table provides a reconciliation of cash and cash equivalents, and restricted cash reported within the balance sheets that sum to the total of the same amounts shown in the statements of cash flows.
|
September 30, |
|
||||||
|
|
2018 |
|
|
2017 |
|
||
|
|
(in thousands) |
|
|||||
Cash and cash equivalents |
|
$ |
41,353 |
|
|
$ |
25,407 |
|
Restricted cash |
|
|
15 |
|
|
|
15 |
|
Total cash, cash equivalents, and restricted cash shown in the statements of cash flows |
|
$ |
41,368 |
|
|
$ |
25,422 |
|
Fair Value Measurements
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability, or an exit price, in the principal or most advantageous market for that asset or liability in an orderly transaction between market participants on the measurement date, and establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs, where available, and minimizes the use of unobservable inputs when measuring fair value. The Company determined the fair value of financial assets and liabilities using the fair value hierarchy that describes three levels of inputs that may be used to measure fair value, as follows:
Level 1—Quoted prices in active markets for identical assets and liabilities;
Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
The carrying amounts of accounts receivable, prepaid expenses, accounts payable and accrued compensation approximate fair value due to the short-term nature of these items.
The fair value of the Company’s financial assets and liabilities is measured on a recurring basis by level within the fair value hierarchy. See Note 3.
The fair value of the Company’s outstanding loan (See Note 6) is estimated using the net present value of the payments, discounted at an interest rate that is consistent with market interest rate, which is a Level 2 input. The estimated fair value of the Company’s outstanding loan approximates the carrying amount, as the loan bears a floating rate that approximates the market interest rate.
Deferred Offering Costs
The Company has deferred offering costs consisting of legal, accounting and other fees and costs directly attributable to the Company’s IPO, which was completed on October 1, 2018. The deferred offering costs will be offset against the gross proceeds of the IPO. As of September 30, 2018 and December 31, 2017, $4.6 million and $0.5 million, respectively, of deferred offering costs were recorded within other long-term assets on the balance sheet.
7
Redeemable Convertible Preferred Stock Warrants
The Company accounts for its redeemable convertible preferred stock warrants as a liability, and they are recorded at their estimated fair value, because the warrants may conditionally obligate the Company to transfer assets at some point in the future. At the end of each reporting period, changes in the estimated fair value during the period are recorded in other income (expense), net in the statement of operations. The Company will continue to adjust the liability for changes in estimated fair value until the earlier of the expiration of the warrants, exercise of the warrants, or conversion of the redeemable convertible preferred stock warrants into common stock warrants upon the completion of a liquidation event, including the completion of an IPO, which occurred on October 1, 2018.
Revenue Recognition
Revenue is recognized when persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed or determinable and collectability is reasonably assured.
For multiple-element arrangements, each deliverable within a multiple-deliverable revenue arrangement is accounted for as a separate unit of accounting if both of the following criteria are met: the delivered item or items has value to the customer on a stand-alone basis; and (ii) for an arrangement that includes a general right of return relative to the delivered item, delivery or performance of the undelivered item is considered probable and substantially in management’s control.
The Company recognizes revenue from milestone payments when: (i) the milestone event is substantive and its achievability has substantive uncertainty at the inception of the agreement, and the Company has completed its performance obligations related to the achievement of the milestone. Milestone payments are considered substantive if all of the following conditions are met: the milestone payment (a) is commensurate with either the Company’s performance subsequent to the inception of the arrangement to achieve the milestone or the enhancement of the value of the delivered item or items as a result of a specific outcome resulting from the Company’s performance subsequent to the inception of the arrangement to achieve the milestone, (b) relates solely to past performance, and (c) is reasonable relative to all of the deliverables and payment terms (including other potential milestone consideration) within the arrangement.
Determining whether and when these revenue recognition criteria have been satisfied often involves assumptions and judgments that can have a significant impact on the timing and amount of reported revenue. Changes in assumptions or judgments or changes to the elements in an arrangement could cause a material increase or decrease in the amount of revenue that is reported in a particular period.
Under certain collaborative arrangements, the Company is entitled to payments for certain research and development activities and for providing product and other related materials. The Company’s policy is to account for such payments by its collaboration partners as collaboration revenue.
Research and Development
Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities: salaries, employee benefits, laboratory supplies, outsourced research and development expenses, professional services and allocated facilities-related costs. Amounts incurred in connection with collaboration arrangements are also included as a research and development expense.
Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized and recognized as an expense as the goods are delivered or the related services are performed.
For outsourced research and development expenses, such as professional fees payable to third parties for preclinical studies, clinical trials and research services, and other consulting costs, the Company estimates the expenses based on the services performed, pursuant to contracts with research institutions that conduct and manage preclinical studies, clinical trials and research services on its behalf. The Company estimates these expenses based on discussions with internal management personnel and external service providers as to the progress or stage of completion of services and the contracted fees to be paid for such services. If the actual timing of the performance of services or the level of effort varies from the original estimates, the Company will adjust the accrual accordingly. Payments made to third parties under these arrangements in advance of the performance of the related services by the third parties are recorded as prepaid expenses until the services are rendered.
8
Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration for potential dilutive common shares. Basic net loss per share is the same as diluted net loss per share as the inclusion of all potential dilutive common shares would have been anti-dilutive.
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”), or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial statements upon adoption. Under the Jumpstart Our Business Startups Act of 2012, as amended (the “JOBS Act”), the Company meets the definition of an emerging growth company, and has elected the extended transition period for complying with new or revised accounting standards pursuant to Section 107(b) of the JOBS Act.
New Accounting Pronouncements Not Yet Adopted
In May 2014, the FASB issued ASU No. 2014-09 (Topic 606), Revenue from Contracts with Customers. In August 2015, the FASB issued ASU No. 2015-14 (Topic 606), Revenue from Contracts with Customers: Deferral of the Effective Date, which delayed the effective date of ASU 2014-09 by one year. ASU 2014-09, as amended, became effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. For entities other than public entities, the standard is effective for fiscal years beginning after December 15, 2018, and interim periods beginning after December 15, 2019. Early adoption is permitted. ASU 2014-09 also permits two methods of adoption: retrospectively to each prior reporting period presented (full retrospective method), or retrospectively with the cumulative effect of initially applying the guidance recognized at the date of initial application (the modified retrospective method). The Company is in the process of evaluating the effect this guidance will have on revenue recognition for its collaboration and license agreements.
The core principle of ASU 2014-09 is that an entity should recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. ASU 2014-09 defines a five-step process to achieve this core principle and, in doing so, it is possible more judgment and estimates may be required within the revenue recognition process than required under existing U.S. generally accepted accounting pronouncements. All of the Company’s revenue is currently generated from up-front payments, research and development services, and milestone and contingent payments under its collaboration arrangements. The Company is currently evaluating its collaboration agreements to determine the impact of adopting ASU 2014-09, inclusive of available transitional methods, on its financial statements and related disclosures.
In January 2016, the FASB issued ASU 2016-01 (Topic 825), Recognition and Measurement of Financial Assets and Financial Liabilities, which will change how to recognize, measure, present and make disclosures about certain financial assets and financial liabilities. Under ASU 2016-01, if an entity designates a financial liability under the fair value option (“FVO”) in accordance with ASC 825, the entity shall measure the financial liability at fair value with qualifying changes in fair value recognized in net income. The entity shall present separately in other comprehensive income the portion of the total change in the fair value of the liability that results from a change in the instrument-specific credit risk.
For public business entities, ASU 2016-01 is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. For all other entities, the guidance is effective for fiscal years beginning after December 15, 2018, and interim periods within fiscal years beginning after December 15, 2019. All entities can early adopt the provision related to financial liabilities measured using the FVO in ASC 825 for financial statements of annual or interim periods that have not yet been issued or made available for issuance. The Company does not expect the adoption of this amendment will have a material impact on its financial statements.
9
In February 2016, the FASB issued Accounting Standards Update (ASU) No. 2016-02, Leases (Topic 842), (“ASC 842”). ASC 842 supersedes the lease recognition requirements in ASC 840, Leases. ASC 842 clarifies the definition of a lease and requires lessees to recognize right-of-use assets and lease liabilities for all leases, including those classified as operating leases under previous lease accounting guidance. The guidance is effective for nonpublic business entities for fiscal years and interim periods beginning after December 15, 2019, with early adoption permitted. Originally, entities were required to adopt ASU 2016-02 using a modified retrospective transition method. However, in July 2018, the FASB issued ASU 2018-11, Leases (Topic 842): Targeted Improvements, which provides entities with an additional transition method. Under ASU 2018-11, entities have the option of initially applying ASC 842 at the adoption date, rather than at the beginning of the earliest period presented, and recognizing the cumulative effect of applying the new standard as an adjustment to beginning retained earnings in the year of adoption while continuing to present all prior periods under previous lease accounting guidance. The Company expects to elect this transition method at the adoption date of January 1, 2020. The Company is currently evaluating the impact of adopting this guidance on the Company’s financial statements. The Company currently expects that its operating lease commitments will be subject to the new standard and recognized as right-of-use assets and operating lease liabilities upon adoption of this standard, which will increase the total assets and total liabilities that it reports relative to such amounts prior to adoption.
In August 2016, the FASB issued ASU 2016-15 (“ASC Topic 230”), Classification of Certain Cash Receipts and Cash Payments. The new guidance clarifies the classification of certain cash receipts and cash payments in the statement of cash flows, including debt prepayment or extinguishment costs, settlement of contingent consideration arising from a business combination, insurance settlement proceeds, and distributions from certain equity method investees. ASU 2016-15 is effective for annual periods beginning after December 15, 2017. Early adoption is permitted. The Company is in the process of assessing the impact, if any, of this ASU on its financial statements. The Company does not expect that the adoption of this amendment will have a material impact on its financial statements.
In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (Topic 808), Clarifying the interaction between Topic 808 and Topic 606, or ASU No. 2018-18. The amendments in ASU No. 2018-18 provide guidance on whether certain transactions between collaborative arrangement participants should be accounted for with revenue under Topic 606. For public business entities, the amendments in ASU No. 2018-18are effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. For all other entities, the amendments are effective for fiscal years beginning after December 15, 2020, and interim periods within fiscal years beginning after December 15, 2021. Early adoption is permitted. An entity may not adopt the amendments earlier than its adoption date of Topic 606. The Company is currently evaluating the effect of this new guidance on its financial statements.
3. Fair Value Measurements
The following table sets forth the fair value of the Company’s financial assets and liabilities measured on a recurring basis by level within the fair value hierarchy:
|
September 30, 2018 |
|
||||||||||||||
|
|
Total |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
||||
|
|
(in thousands) |
|
|||||||||||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
31,879 |
|
|
$ |
31,879 |
|
|
$ |
– |
|
|
$ |
– |
|
Commercial paper |
|
|
34,939 |
|
|
|
– |
|
|
|
34,939 |
|
|
|
– |
|
Corporate debt securities |
|
|
15,774 |
|
|
|
– |
|
|
|
15,774 |
|
|
|
– |
|
Asset-backed securities |
|
|
16,864 |
|
|
|
– |
|
|
|
16,864 |
|
|
|
– |
|
U.S. government agency securities |
|
|
23,767 |
|
|
|
– |
|
|
|
23,767 |
|
|
|
– |
|
Total |
|
$ |
123,223 |
|
|
$ |
31,879 |
|
|
$ |
91,344 |
|
|
$ |
– |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Redeemable convertible preferred stock warrant liability |
|
$ |
867 |
|
|
$ |
– |
|
|
$ |
– |
|
|
$ |
867 |
|
Total |
|
$ |
867 |
|
|
$ |
– |
|
|
$ |
– |
|
|
$ |
867 |
|
10
|
December 31, 2017 |
|
||||||||||||||
|
Total |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|||||
|
|
(in thousands) |
|
|||||||||||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
6,578 |
|
|
$ |
6,578 |
|
|
$ |
– |
|
|
$ |
– |
|
Commercial paper |
|
|
7,689 |
|
|
|
– |
|
|
|
7,689 |
|
|
|
– |
|
Corporate debt securities |
|
|
800 |
|
|
|
– |
|
|
|
800 |
|
|
|
– |
|
U.S. government agency securities |
|
|
3,893 |
|
|
|
– |
|
|
|
3,893 |
|
|
|
– |
|
Total |
|
$ |
18,960 |
|
|
$ |
6,578 |
|
|
$ |
12,382 |
|
|
|
– |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Redeemable convertible preferred stock warrant liability |
|
$ |
1,708 |
|
|
$ |
– |
|
|
$ |
– |
|
|
$ |
1,708 |
|
Total |
|
$ |
1,708 |
|
|
$ |
– |
|
|
$ |
– |
|
|
$ |
1,708 |
|
Where applicable, the Company uses quoted market prices in active markets for identical assets to determine fair value. This pricing methodology applies to Level 1 investments, which are composed of money market funds.
If quoted prices in active markets for identical assets are not available, then the Company uses quoted prices for similar assets or inputs other than quoted prices that are observable, either directly or indirectly. These investments are included in Level 2 and consist of commercial paper, corporate debt securities, and U.S. government agency securities. These assets are valued using market prices when available, adjusting for accretion of the purchase price to face value at maturity.
A financial instrument’s categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.
In certain cases where there is limited activity or less transparency around inputs to valuation, securities are classified as Level 3 within the valuation hierarchy. Level 3 liabilities that are measured at estimated fair value on a recurring basis consist of the redeemable convertible preferred stock warrant liability. Refer to Note 8 for the valuation techniques used to measure fair value and a description of the inputs and the information used to develop the inputs to the valuation models.
Generally, increases or decreases in the fair value of the underlying redeemable convertible preferred stock would result in a directionally similar impact in the fair value measurement of the associated warrant liability. There were no transfers within the hierarchy during the nine months ended September 30, 2018 and 2017.
The following table sets forth a summary of the changes in the estimated fair value of the Company’s redeemable convertible preferred stock warrant liability:
Redeemable Convertible Preferred Stock Warrant Liability |
|
||
|
(in thousands) |
|
|
Balance as of December 31, 2017 |
$ |
1,708 |
|
Proceeds from issuances of common stock upon exercise of warrants |
|
(2 |
) |
Changes in estimated fair value of warrant liability included in other income (expense), net |
|
(839 |
) |
Balance as of September 30, 2018 |
$ |
867 |
|
11
4. Cash Equivalents and Marketable Securities
Cash equivalents and marketable securities consisted of the following:
|
September 30, 2018 |
|
||||||||||||||
|
|
Amortized Cost Basis |
|
|
Unrealized Gains |
|
|
Unrealized Losses |
|
|
Fair Value |
|
||||
|
|
(in thousands) |
|
|||||||||||||
Money market funds |
|
$ |
31,879 |
|
|
$ |
– |
|
|
$ |
– |
|
|
$ |
31,879 |
|
Commercial paper |
|
|
34,939 |
|
|
|
– |
|
|
|
– |
|
|
|
34,939 |
|
Corporate debt securities |
|
|
15,781 |
|
|
|
1 |
|
|
|
(8 |
) |
|
|
15,774 |
|
Asset-based securities |
|
|
16,876 |
|
|
|
– |
|
|
|
(12 |
) |
|
|
16,864 |
|
U.S. government agencies |
|
|
23,776 |
|
|
|
– |
|
|
|
(9 |
) |
|
|
23,767 |
|
Total |
|
|
123,251 |
|
|
|
1 |
|
|
|
(29 |
) |
|
|
123,223 |
|
Less amounts classified as cash equivalents |
|
|
(41,626 |
) |
|
|
– |
|
|
|
– |
|
|
|
(41,626 |
) |
Total marketable securities |
|
$ |
81,625 |
|
|
$ |
1 |
|
|
$ |
(29 |
) |
|
$ |
81,597 |
|
|
December 31, 2017 |
|
||||||||||||||
|
|
Amortized Cost Basis |
|
|
Unrealized Gains |
|
|
Unrealized Losses |
|
|
Fair Value |
|
||||
|
|
(in thousands) |
|
|||||||||||||
Money market funds |
|
$ |
6,578 |
|
|
$ |
– |
|
|
$ |
– |
|
|
$ |
6,578 |
|
Commercial paper |
|
|
7,689 |
|
|
|
– |
|
|
|
– |
|
|
|
7,689 |
|
Corporate debt securities |
|
|
800 |
|
|
|
– |
|
|
|
– |
|
|
|
800 |
|
U.S. government agencies |
|
|
3,893 |
|
|
|
– |
|
|
|
– |
|
|
|
3,893 |
|
Total |
|
|
18,960 |
|
|
|
– |
|
|
|
– |
|
|
|
18,960 |
|
Less amounts classified as cash equivalents |
|
|
(18,960 |
) |
|
|
– |
|
|
|
– |
|
|
|
(18,960 |
) |
Total marketable securities |
|
$ |
– |
|
|
$ |
– |
|
|
$ |
– |
|
|
$ |
– |
|
All marketable securities as of September 30, 2018 had maturities of less than one year.
12
5. Collaboration Agreements and Supply Agreements
The Company has recognized revenue as follows:
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|||||||||||
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
||||
|
|
(in thousands) |
|
|
(in thousands) |
|
||||||||||
Collaboration revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Celgene Corporation (“Celgene”)—related party: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of up-front payment |
|
$ |
1,655 |
|
|
$ |
2,642 |
|
|
$ |
4,912 |
|
|
$ |
16,355 |
|
Research and development services |
|
|
5 |
|
|
|
– |
|
|
|
103 |
|
|
|
– |
|
Milestones and contingent payments |
|
|
– |
|
|
|
13,112 |
|
|
|
|
|
|
|
25,937 |
|
Total |
|
|
1,660 |
|
|
|
15,754 |
|
|
|
5,015 |
|
|
|
42,292 |
|
Merck Sharp & Dohme Corporation (“Merck”)—related party: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of up-front payment |
|
|
2,818 |
|
|
|
– |
|
|
|
2,818 |
|
|
|
– |
|
Research and development services |
|
|
696 |
|
|
|
– |
|
|
|
696 |
|
|
|
– |
|
Total |
|
|
3,514 |
|
|
|
– |
|
|
|
3,514 |
|
|
|
– |
|
Merck KGaA, Darmstadt, Germany (operating in the United States and Canada under the name “EMD Serono”): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of up-front payment |
|
|
1,038 |
|
|
|
1,030 |
|
|
|
3,104 |
|
|
|
3,090 |
|
Research and development services |
|
|
712 |
|
|
|
715 |
|
|
|
2,322 |
|
|
|
2,319 |
|
Total |
|
|
1,750 |
|
|
|
1,745 |
|
|
|
5,426 |
|
|
|
5,409 |
|
Total collaboration revenue |
|
$ |
6,924 |
|
|
$ |
17,499 |
|
|
$ |
13,955 |
|
|
$ |
47,701 |
|
Other revenue—related parties: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Celgene Corporation: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Development and manufacturing services and clinical product supply |
|
$ |
330 |
|
|
$ |
– |
|
|
$ |
3,894 |
|
|
$ |
– |
|
SutroVax: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supply and other |
|
|
582 |
|
|
|
– |
|
|
|
1,484 |
|
|
|
– |
|
Total other revenue—related parties |
|
$ |
912 |
|
|
$ |
– |
|
|
$ |
5,378 |
|
|
$ |
– |
|
Total revenue |
|
$ |
7,836 |
|
|
$ |
17,499 |
|
|
$ |
19,333 |
|
|
$ |
47,701 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2014 Celgene Agreement
In September 2014, the Company signed a Collaboration and License Agreement with Celgene (the “2014 Celgene Agreement”) to discover and develop bispecific antibodies and/or antibody-drug conjugates (“ADCs”), focused primarily on the field of immuno-oncology, using the Company’s proprietary integrated cell-free protein synthesis platform, XpressCF+™.
Upon signing the 2014 Celgene Agreement, the Company received an up-front, nonrefundable payment totaling $83.1 million. The Company was recognizing revenues from the up-front payment ratably over an approximate three-year period starting in September 2014.
In March 2015, the Company received a $15.0 million contingent payment (“March 2015 payment”) from Celgene under the 2014 Celgene Agreement that provided Celgene a right to access certain of the Company’s technology for use in conjunction with certain Celgene intellectual property. In June 2016, the Company received a $25.0 million milestone (“June 2016 payment”) upon completion of certain preclinical activities. The March 2015 and June 2016 payments were being recognized as revenue over the remaining portion of the estimated period of the research term prior to entering into the 2017 Celgene Agreement.
13
In August 2017, the Company entered into the 2017 Celgene Agreement to refocus its 2014 Celgene Agreement on four programs that are advancing through preclinical development, including an ADC program targeting B cell maturation antigen.
Upon signing of the 2017 Celgene Agreement, the Company received an option fee payment of $12.5 million in August 2017 and is entitled to receive a second option fee payment of $12.5 million following the first investigational new drug (“IND”) clearance, if any, for one of the four programs, if Celgene desires to maintain its option to acquire the U.S. rights to develop and commercialize a second collaboration program to reach IND status. If Celgene exercises its option to acquire from the Company U.S. rights to a second collaboration program, it will make an option exercise fee payment to the Company, the amount of which depends on which program reaches IND status. The Company determined that the initial $12.5 million payment should be deferred and recognized over the entire potential period during which Celgene has an option to acquire worldwide rights to a second collaboration program. Consequently, the Company is recognizing revenue from such payment ratably over an approximate three-year period starting in August 2017 and ending in September 2020. In September 2017, the Company earned a $10.0 million milestone for certain manufacturing accomplishments, which payment was received from Celgene in October 2017. The entire $10.0 million amount was recognized as revenue when earned, as the Company had completed its performance obligations related to the achievement of the substantive milestone.
The Company evaluated the terms of the 2017 Celgene Agreement, relative to the 2014 Celgene Agreement, and determined the 2017 Celgene Agreement to be a material modification to the 2014 Celgene Agreement for financial reporting purposes. As a result, the Company determined that the remaining deferred revenue balance of $8.2 million as of the date of entering into the 2017 Celgene Agreement, related to Celgene payments to the Company under the 2014 Celgene Agreement, will also be recognized ratably over an approximate three-year period starting in August 2017 and ending in September 2020 (the “Celgene Agreements”). The Company has received and will be eligible to receive financial support for research and development services assigned to the Company by Celgene, based on an agreed-upon level of full-time equivalent personnel effort and related reimbursement rate, which will be recognized as revenue as the related reimbursable activities approved by Celgene and the Company are performed by the Company.
Under the terms of the 2017 Celgene Agreement, the Company is entitled to earn development and regulatory contingent payments for each of the four programs under the collaboration, and royalties on sales of any commercial products that may result from the 2017 Celgene Agreement. As of September 30, 2018, the Company is eligible to receive a potential future payment for manufacturing activities of $10.0 million, which is considered to be a substantive milestone for which the related payment will be recognized as revenue upon achievement. In addition, for licensed products for which Celgene holds worldwide rights, the Company is eligible to receive aggregate milestone and option fee payments of up to $295.0 million for certain licensed products and up to $393.7 million for certain other licensed products under the collaboration, if approved in multiple indications, and, depending on the licensed product, tiered royalties ranging from mid-single digits to low teen percentages on worldwide sales of any commercial products that may result from the 2017 Celgene Agreement. Additionally, for licensed products for which Celgene holds ex-U.S. rights, the Company will also be eligible to receive pre-commercial contingent payments and tiered royalties ranging from mid to high single digit percentages. The contingent payments under the 2017 Celgene Agreement are not considered to be substantive milestones because the receipt of such payments is based solely on the performance of Celgene.
Celgene may terminate the 2017 Celgene Agreement at any time with 120 days’ prior written notice. Either the Company or Celgene has the right to terminate the 2017 Celgene Agreement based on the other party’s uncured material breach, challenge of the validity and enforceability of intellectual property, or bankruptcy.
As of September 30, 2018 and December 31, 2017, there was $13.1 million and $18.0 million, respectively, of deferred revenue related to payments received by the Company under the Celgene Agreements.
As of September 30, 2018 and December 31, 2017, the Company had $0.3 million and $0.8 million, respectively, of receivables from Celgene related to the Celgene Agreements, which are included in accounts receivable on the balance sheet.
14
2018 Master Services Agreement
In March 2018, the Company entered into a Master Development and Clinical Manufacturing Services Agreement (the “Master Services Agreement”) with Celgene, wherein Celgene requested the Company to provide development, manufacturing and supply chain management services, including clinical product supply. The consideration for the services is based on an agreed-upon level of full-time equivalent personnel effort and related reimbursement rate in addition to agreed-upon pricing for the clinical product supply.
For the three and nine months ended September 30, 2018, the Company earned $0.3 million and $3.9 million, respectively, in other revenue-related parties under the Master Services Agreement
2018 Merck Agreement
In July 2018, the Company entered into an Exclusive Patent License and Research Collaboration Agreement (the “2018 Merck Agreement”) with Merck to jointly develop up to three research programs focusing on cytokine derivatives for cancer and autoimmune disorders.
Under the 2018 Merck Agreement, the Company received from Merck an upfront payment of $60.0 million in August 2018 for the identification of and the pre-clinical research and development of two target programs, with an option for Merck to engage the Company to continue these activities for a third program upon the payment of an additional amount. The Company identified multiple deliverables under the 2018 Merck Agreement, which include access to certain intellectual property rights, performance of research and development services, and joint project team participation. The Company considered the provisions of the multiple-element arrangement guidance in determining whether access to the intellectual property rights under the arrangement has stand-alone value. Based on the Company’s expertise in applying its proprietary technology, the Company concluded that there is no stand-alone value of the intellectual property rights accessed by Merck. Consequently, the Company determined that the identified deliverables comprise a single unit of accounting, and the up-front cash payment was deferred and will be recognized over the relevant estimated period during which the Company has significant obligations to perform research and development services and participate in joint project team activities for Merck. Consequently, the Company is recognizing revenues from the up-front payment ratably over an estimated four-year period starting in July 2018. Revenue for research and development services under the 2018 Merck Agreement will be recognized as the related activities are performed by the Company.
The Company is also eligible to receive aggregate milestone payments of up to $1.6 billion, assuming the development and sale of all therapeutic candidates and all possible indications identified under the collaboration. If one or more products from each of the target programs are developed for non-oncology or a single indication, the Company will be eligible for reduced aggregate milestone payments. In addition, the Company is eligible to receive tiered royalties ranging from mid-single digit to low teen percentages on the worldwide sales of any commercial products that may result from the collaboration. Additionally, Merck purchased 74,794,315 shares of the Company’s Series E redeemable convertible preferred stock at a price per share of $0.2674, resulting in gross proceeds of $20.0 million. Concurrent with the Company’s IPO, which was completed on October 1, 2018, Merck purchased 666,666 shares of common stock at a price per share of $15.00, resulting in proceeds of approximately $10.0 million. Merck may terminate the Merck Agreement at any time with 60 days’ prior written notice. Either the Company or Merck has the right to terminate the Merck Agreement based on the other party’s uncured material breach or bankruptcy.
As of September 30, 2018, there was $57.2 million of deferred revenue related to payment received by the Company under the 2018 Merck Agreement. As of September 30, 2018, the Company had $0.8 million receivable from Merck related to the Merck Agreement, which is included in accounts receivable on the balance sheet.
EMD Serono Agreement
The Company signed a Collaboration Agreement and a License Agreement with EMD Serono in May 2014 and September 2014, respectively, which were entered into in contemplation of each other and therefore treated as a single agreement for accounting purposes. The Collaboration Agreement was terminated upon execution of the License Agreement (the “MDA Agreement”), which agreement is to develop ADCs for multiple cancer targets.
Upon signing the Collaboration Agreement, the Company received an up-front, nonrefundable, non-creditable payment totaling $10.0 million. Upon signing the MDA Agreement, the Company received an additional up-front, nonrefundable payment totaling $10.0 million and will receive financial support for research and development services to be provided by the Company, based on an agreed-upon level of full-time equivalent personnel effort and related reimbursement rate.
15
The Company is recognizing revenues from the up-front payments ratably over an estimated five-year period starting in June 2014. Revenue for research and development services under the MDA Agreement will be recognized as revenue as the related reimbursable activities approved by EMD Serono and the Company are performed by the Company.
The Company is eligible to receive up to $52.5 million for each product developed under the MDA Agreement, primarily from pre-commercial contingent payments. In addition, the Company is eligible to receive tiered royalties ranging from low-to-mid single digit percentages, along with certain additional one-time royalties, on worldwide sales of any commercial products that may result from the MDA Agreement. The MDA Agreement term expires on a product-by-product and country-by-country basis. Upon expiration, EMD Serono will have a fully paid-up, royalty-free, perpetual, and irrevocable non-exclusive license, with the right to grant sublicenses, under certain Company intellectual property rights. EMD Serono may terminate the MDA Agreement at any time with 90 days’ prior written notice or upon the inability of the Company to provide EMD Serono access to a specified number of cancer drug targets. Either the Company or EMD Serono has the right to terminate the MDA Agreement based on the other party’s uncured material breach or bankruptcy.
As of September 30, 2018 and December 31, 2017, there was $2.8 million and $5.9 million, respectively, of deferred revenue related to payments received by the Company under the MDA Agreement. As of September 30, 2018 and December 31, 2017, the Company had $0.7 million and $0.8 million, respectively, of receivables from EMD Serono related to the MDA Agreement, which are included in accounts receivable on the balance sheet.
SutroVax, Inc. Supply Agreement
In May 2018, the Company entered into a Supply Agreement (the “Supply Agreement”) with SutroVax, Inc., (“SutroVax”), wherein SutroVax engaged the Company to supply extracts and custom reagents, as requested by SutroVax. The pricing is based on an agreed upon cost plus arrangement. For the three and nine months ended September 30, 2018, the Company recognized $0.6 million and $1.5 million, respectively, in other revenue-related parties under the Supply Agreement. As of September 30, 2018, the Company had $0.6 million receivable from SutroVax related to the Supply Agreement, which is included in accounts receivable on the balance sheet.
The Leukemia & Lymphoma Society, Inc.
In August 2018, the Company entered into a Research, Development and Commercialization Agreement (the “LLS Agreement”) with The Leukemia & Lymphoma Society (“LLS”), under which LLS has agreed to contribute up to $6.0 million in clinical development funding for STRO-001, the Company’s CD74-targeting ADC to treat relapsed and/or refractory multiple myeloma and non-Hodgkin lymphoma. The funding will be provided in installments based upon the achievement of funding milestones, with the initial payment of $0.5 million received by the Company upon execution of the LLS Agreement. As of September 30, 2018, the Company had received total payments from LLS of $1.0 million, which will be reflected as a reduction of research and development expenses over an estimated period ending in 2021, as eligible STRO-001 clinical development costs are incurred by the Company. In consideration for the funding to the Company under the LLS Agreement, the Company may be required to make payments to LLS based on pre-specified late-stage clinical development, regulatory and commercialization milestones and should the Company enter into certain transactions relating to STRO-001 with a third party. The Company will recognize such payments, if any, in the period they are incurred as the contingent payments are not an unconditional purchase obligation. The LLS Agreement terminates upon the earlier of (a) fulfillment of all payment obligations by both parties or (b) 12 years after the effective date. LLS may terminate the LLS Agreement at any time with 60 days’ prior written notice. Either the Company or LLS has the right to terminate the LLS Agreement based on the other party’s uncured material breach. As of September 30, 2018, there was approximately $1.0 million of other liabilities related to payments received by the Company under the LLS Agreement.
6. Loan and Security Agreement
In August 2017, the Company entered into a loan and security agreement with Oxford and SVB under which it borrowed $15.0 million (the “August 2017 Loan”). The loan is due in 30 monthly installments from March 2019 through its repayment in August 2021, with interest-only monthly payments until March 2019. If certain qualified funding events occur, the loan will be due in 24 monthly installments from September 2019 through its repayment in August 2021, with interest-only payments until September 2019. While the aforementioned qualified funding events occurred during the quarter ended September 30, 2018, the Company intends currently to commence repayment of the loan in March 2019.
16
The August 2017 Loan is secured by all assets of the Company, excluding intellectual property and certain other assets. The August 2017 Loan contains customary affirmative and restrictive covenants, including with respect to fundamental transactions, the incurrence of additional indebtedness, grant liens, pay any dividend or make any distributions to the Company’s holders, make investments, merge or consolidate with any other person, or engage in transactions with its affiliates, but does not include any financial covenants. The loan agreement provides that an event of default will occur if, among other triggers, there occurs any circumstances that could reasonably be expected to result in a material adverse effect on the Company’s business, operations or condition, or on its ability to perform its obligations under the loan. The loan agreement also includes customary representations and warranties, other events of default and termination provisions.
The Company disclosed in its audited financial statements as of December 31, 2017 that there was substantial doubt about its ability to continue as a going concern given its continuing operating losses and its current available capital resources, which could be deemed to be an event of default if such condition was considered to have a material adverse effect on the Company’s business, operations or condition. As a result, the Company classified the entire debt balance as a current liability as of December 31, 2017 given that a determination of such an event of default is outside of the Company’s control. As of September 30, 2018, the Company has classified $3.2 million of the outstanding debt balance as current and $11.5 million as non-current, which reflects the scheduled repayment terms under the August 2017 Loan.
The interest charges on the loan will be based on a floating rate that equals the greater of 7.39% or the sum of the 30-day U.S. Dollar London Interbank Offered Rate (“LIBOR”) plus 6.40%. For the nine months ended September 2018, the average interest rate was 8.28%. In addition, the Company will make a final payment equal to 3.83% of the original principal amount of the loan, or $574,500, which will be accrued over the term of the loan using the effective-interest method. As of September 30, 2018, total interest expense accrued was $0.2 million.
In connection with the August 2017 Loan, the Company issued to Oxford and SVB a warrant to purchase 454,820 shares and 227,410 shares, respectively, of Series D-2 redeemable convertible preferred stock at an exercise price of $0.6596 per share (the “2017 Warrant”). If there is a subsequent convertible preferred stock or other senior equity securities financing with a per share price less than the Series D-2 redeemable convertible preferred per share price, then the warrant shall instead be to purchase such class of shares, based on the per share price of such. In May and July 2018, the Company raised a total of $85.4 million in funding through the sale and issuance of 319,305,718 shares of Series E redeemable convertible preferred stock, at $0.2674 per share. Given that the price per share of the Series E redeemable convertible preferred stock was less than the Series D-2 redeemable convertible preferred per share price, the 2017 Warrant converted into a warrant to purchase a total of 1,682,871 shares of Series E redeemable convertible preferred stock at an exercise price of $0.2674 per share. The warrants were exercisable from the date of issuance and have a 10-year term. The estimated fair value upon issuance of the 2017 Warrant based on Series D-2 redeemable convertible preferred stock was $329,000, which was recorded as redeemable convertible preferred stock warrant liability. The fair value of the warrant at the date of issuance was determined using an Option Pricing Method and was recorded as a redeemable convertible preferred stock warrant liability with an offset to debt discount on the associated borrowings on the Company’s balance sheet. The debt discount is being amortized to interest expense over the repayment period of the loan using the effective-interest method.